EP2741809B1 - Procédé de revêtement de dispositifs à l'aide d'électrofilage et de soufflage à l'état fondu - Google Patents

Procédé de revêtement de dispositifs à l'aide d'électrofilage et de soufflage à l'état fondu Download PDF

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Publication number
EP2741809B1
EP2741809B1 EP12766193.2A EP12766193A EP2741809B1 EP 2741809 B1 EP2741809 B1 EP 2741809B1 EP 12766193 A EP12766193 A EP 12766193A EP 2741809 B1 EP2741809 B1 EP 2741809B1
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EP
European Patent Office
Prior art keywords
fibrous matrix
electrode
forming
electrospinning
matrix
Prior art date
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EP12766193.2A
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German (de)
English (en)
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EP2741809A1 (fr
Inventor
Devon N. Arnholt
Douglas D. Pagoria
Jeannette C. Polkinghorne
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Cardiac Pacemakers Inc
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Cardiac Pacemakers Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/0007—Electro-spinning
    • D01D5/0015—Electro-spinning characterised by the initial state of the material
    • D01D5/0023—Electro-spinning characterised by the initial state of the material the material being a polymer melt
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/0007—Electro-spinning
    • D01D5/0061—Electro-spinning characterised by the electro-spinning apparatus
    • D01D5/0076—Electro-spinning characterised by the electro-spinning apparatus characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid
    • D01D5/0084—Coating by electro-spinning, i.e. the electro-spun fibres are not removed from the collecting device but remain integral with it, e.g. coating of prostheses
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2321/00—Fibres made from polymers obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • D10B2321/08—Fibres made from polymers obtained by reactions only involving carbon-to-carbon unsaturated bonds polymers of unsaturated carboxylic acids or unsaturated organic esters, e.g. polyacrylic esters, polyvinyl acetate
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2331/00—Fibres made from polymers obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polycondensation products
    • D10B2331/06—Fibres made from polymers obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polycondensation products polyethers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49002—Electrical device making
    • Y10T29/49117—Conductor or circuit manufacturing
    • Y10T29/49204—Contact or terminal manufacturing
    • Y10T29/49208—Contact or terminal manufacturing by assembling plural parts
    • Y10T29/4922—Contact or terminal manufacturing by assembling plural parts with molding of insulation
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49002—Electrical device making
    • Y10T29/49117—Conductor or circuit manufacturing
    • Y10T29/49204—Contact or terminal manufacturing
    • Y10T29/49224—Contact or terminal manufacturing with coating

Definitions

  • the present invention relates to methods for manufacturing medical devices. More specifically, the invention relates to methods for coating medical devices and to coated medical devices.
  • Cardiac pacing leads are well known and widely employed for carrying pulse stimulation signals to the heart from a battery operated pacemaker, or other pulse generating means, as well as for monitoring electrical activity of the heart from a location outside of the body. Electrical energy is applied to the heart via an electrode to return the heart to normal rhythm. Some factors that affect electrode performance include polarization at the electrode/tissue interface, electrode capacitance, sensing impedance, and voltage threshold. In all of these applications, it is highly desirable to optimize electrical performance characteristics at the electrode/tissue interface.
  • documents US 2010/0241204 A1 and US 2011/021899 A1 describe an electrically conductive coating composition for a medical device that includes a polymeric mixture, an electrically conductive material dispersed within the polymeric mixture and, optionally, one or more bioactive agents.
  • a lead which includes a lead body extending from a lead proximal end portion to a lead distal end portion and having an intermediate portion therebetween.
  • One or more tissue sensing/stimulation electrodes are disposed along the lead body, one or more terminal connections are disposed along the lead proximal end portion.
  • the lead further includes one or more conductors contained within the lead body extending between the tissue sensing/stimulation electrodes and the terminal connections, and a fibrous matrix coating is disposed onto at least a portion of the lead body and/or sensing/stimulation electrodes.
  • Recognized performance challenges of materials conventionally used as electrodes include difficulty controlling tissue in-growth, inflammation in the vicinity of the implanted device and/or the formation of fibrous scar tissue. These challenges may lead to difficulty in extracting the lead and/or reduced electrode performance over time.
  • FIG. 1 is a partial cross-sectional view of a medical electrical lead 10, according to various embodiments of the present disclosure.
  • the medical electrical lead 10 can be configured for implantation within a patient's heart.
  • the medical electrical lead 10 is configured for implantation within a patient's neurovascular regions.
  • the lead 10 can be a lead for a cochlear implant.
  • the medical electrical lead 10 includes an elongated, insulative lead body 12 extending from a proximal end 16 to a distal end 20.
  • the proximal end 16 is configured to be operatively connected to a pulse generator via a connector 24.
  • At least one conductor 32 extends from the connector 24 at the proximal end 16 of the lead 10 to one or more electrodes 28 at the distal end 20 of the lead 10.
  • the conductor 32 can be a coiled or cable conductor.
  • the lead can include a combination of coiled and cable conductors.
  • the conductor can have either a co-radial or a co-axial configuration.
  • the lead body 12 is flexible, but substantially non-compressible along its length, and has a circular cross-section. According to one embodiment of the present disclosure, an outer diameter of the lead body 12 ranges from about 2 to about 15 French. In many embodiments, the lead body 12 does not include a drug collar or plug.
  • the medical electrical lead 10 can be unipolar, bipolar, or multi-polar depending upon the type of therapy to be delivered.
  • each conductor 32 is adapted to be connected to an individual electrode 28 in a one-to-one manner allowing each electrode 28 to be individually addressable.
  • the lead body 12 can include one or more lumens adapted to receive a guiding element such as a guidewire or a stylet for delivery of the lead 10 to a target location within a patient's heart.
  • the electrodes 28 can have any electrode configuration as is known in the art. According to one embodiment of the present disclosure, at least one electrode can be a ring or partial ring electrode. According to another embodiment, at least one electrode 28 is a shocking coil. According to yet another embodiment of the present disclosure, at least one electrode 28 includes an exposed electrode portion and an insulated electrode portion. In some embodiments, a combination of electrode configurations can be used.
  • the electrodes 28 can be coated with or formed from platinum, stainless steel, titanium, tantalum, palladium, MP35N, other similar conductive material, alloys of any of the foregoing including platinum-iridium alloys, and other combinations of the foregoing including clad metal layers or multiple metal materials.
  • the lead body 12 can include one or more fixation members for securing and stabilizing the lead body 12 including the one or more electrodes 28 at a target site within a patient's body.
  • the fixation member(s) can be active or passive.
  • An exemplary active fixation member includes a screw-in fixation member.
  • Examples of passive fixation members can include preformed distal portions of the lead body 12 adapted to bear against vessel walls and/or expandable tines provided at the distal end of the lead body 12.
  • the lead 10 includes a fibrous matrix that is disposed over various parts of the insulative lead body 12.
  • Figures 2A and 2B provide illustrative but nonlimiting examples of regions of the lead 10 that may include a fibrous matrix.
  • Figures 2A and 2B are schematic longitudinal cross-sectional views of the lead 10 of Figure 1 , in which internal structure has been removed for clarity.
  • Figure 2A shows a fibrous matrix 40 disposed over a portion of the insulative lead body 12.
  • the illustrated portion of the insulative lead body 12 may be adjacent an electrode such as the electrode 28, or it may be spaced apart from the electrodes.
  • Figure 2B illustrates a fibrous matrix 40 disposed over the electrode 28. While the fibrous matrix 40 is illustrated as covering all of the electrode 28, in some embodiments the fibrous matrix 40 covers only a small portion of the electrode 28, a substantial portion of the electrode 28, or an intervening fraction of the electrode 28.
  • the fibrous matrix 40 may provide various beneficial functionalities to the lead 10. In some embodiments, the fibrous matrix 40 may improve the abrasion resistance of the lead 10. In some embodiments, the fibrous matrix 40 may improve the electrical or thermal insulation of the lead 10. In some embodiments, the fibrous matrix 40 may provide improved control over tissue ingrowth, particularly at the site of the electrode 28. In certain embodiments, the amount of tissue ingrowth may be determined by tissue extraction in which the force required to remove an implanted lead 10 is measured with an Instron force gauge. In some embodiments, the thickness and average fiber diameter of fibrous matrix 40 impacts tissue ingrowth. The thickness and average fiber diameter of fibrous matrix 40 may also impact the ability to deliver electrophysiological therapy through fibrous matrix 40. In certain embodiments, the fibrous matrix 40 does not significantly impact the impedance of the lead 10.
  • the fibrous matrix 40 includes a plurality of randomly aligned fibers that comprise the matrix.
  • the fibrous matrix 40 may be formed by electrospinning or melt blowing, for example.
  • the fibers may have diameters in the range of about 10-3000 nanometers (nm), for example.
  • the fiber diameter size may be about 40-2000 nm, about 50-1500 nm or about 100-1000 nm, for example.
  • the fiber diameter size may be measured by taking the average size of the fibers.
  • the fibers may have diameters as little as 40 nm, 50 nm, 100 nm or 150 nm and as great as 300 nm, 400 nm, 500 nm, 600 nm, 650 nm, 700 nm, 725 nm, 750 nm or 800nm or may be within any range delimited by any pair of the foregoing values.
  • the fibers may have an average diameter size less than about 800 nm, 750 nm, 725 nm, 700 nm, 600 nm, 500 nm or 400 nm.
  • the fiber matrix 40 may be formed partially or completely with hollow fibers using modified electrospinning and meltblowing techniques.
  • the fibrous matrix 40 may have an average fiber-to fiber-spacing in the range of about 1 to about 100 microns, more particularly from about 10 to about 50 microns, even more particularly from about 10 to about 25 microns.
  • the fiber spacing between adjacent fibers may be adjusted or regulated to control tissue ingrowth while minimizing impact on pacing capability. This can be accomplished, for example, by altering the deposition parameters or deposition material. In other embodiments, tissue in-growth is controlled by the thickness of the matrix.
  • Suitable thicknesses for the fibrous matrix may range from about 0.00254 millimeters (mm) to about 0.254 mm (about 0.0001 inches (in.) to about 0.01 in.), more particularly from about 0.0127 mm to about 0.127 mm (about 0.0005 in. to about 0.005 in.), even more particularly from about 0.0254 mm to about 0.0762 mm (about 0.001 in. to about 0.003 in.).
  • the fibrous matrix 40 may have sufficient fiber spacing to permit ions to flow through the fibrous matrix 40 such that electrical contact may be made with the electrode 28.
  • Suitable non-conductive polymers include homopolymers, copolymers and terpolymers of various polysiloxanes, polyurethanes, fluoropolymers, polyolefins, polyamides and polyesters.
  • the non-conductive material in certain embodiments is free or substantially free of dopant materials that facilitate polymer conductivity.
  • the conductive material may comprises less than 5 weight percent (wt%) dopant, more particularly, less than 1 wt% dopant, even more particularly less than 0.5 wt% dopant.
  • Suitable conductive polymers are disclosed in U.S. patent 7,908,016 .
  • the fibrous matrix 40 is formed from a non-conductive polyurethane material.
  • Suitable polyurethanes may include polycarbonate, polyether, polyester and polyisobutylene (PIB) polyurethanes.
  • PIB polyurethanes are disclosed in U.S. published application 2010/0023104 . Further examples of such copolymers and methods for their synthesis are generally described in WO 2008/060333 , WO 2008/066914 , U.S. Application No.
  • the fibrous matrix 40 is formed from a non-conductive fluoropolymer material.
  • Suitable fluoropolymer materials include polyvinylidene fluoride, poly(vinylidene fluoride-co-hexafluoropropene) (PVDF HFP), polytetrafluoroethylene and expanded polytetrafluoroethylene.
  • the average diameter size of the fibrous matrix 40 may reduce tissue ingrowth.
  • the fibrous matrix 40 may include a polyurethane, such as a polycarbonate polyurethane and have an average diameter size of less than about 800 nm or less than about 750 nm.
  • the fibrous matrix 40 may include PVDF HFP and have an average diameter size of less than about 800 nm or less than about 730 nm.
  • the fibrous matrix 40 may be formed using several different techniques, such as electrospinning and melt blowing. In some embodiments, smaller fiber sizes may be achieved using electrospinning. Figures 3 and 4 schematically illustrate both techniques.
  • Figure 3 provides a schematic illustration of electrospinning.
  • An electric field may be used to draw a polymer solution or melt 54 from a capillary source 52.
  • the capillary source 52 may be a syringe.
  • the polymer solution or melt 54 is drawn to a grounded collector 58.
  • a high voltage power supply 56 may be used to power the process.
  • the elements 60 to be coated may be placed on the collector 58 to be coated. Upon drying, a thin polymeric web 62 may be formed.
  • the fiber sizes may be controlled by adjusting the relative concentration of polymer in the polymer solution or melt 54.
  • the concentration of polymer in the electrospinning solution and solvent selection are important factors in achieving desired fibrous matrix properties, and in particular for controlling porosity and/or fiber size. Additionally, a small amount of a metal salt solution may be added to the electrospinning solution to improve deposition.
  • the electrospinning solution has a polymer concentration of between about 1 wt% and about 40 wt%, more particularly between about 1 wt% and about 30 wt%, even more particularly from about 3 wt% to about 15 wt%, and even more particularly from about 5 wt% to about 15 wt%.
  • Suitable solvents include dimethylformamide, dimethylacetamide, N -methyl-2-pyrrolidone, dimethyl sulfoxide, acetone, cyclohexane tetrohydrofuran as well as mixtures and co-solvents thereof.
  • the polymer may be a polyurethane polymer and the electrospinning solution may have a polymer concentration as little as 1%, 3% or 5%, or as great as 15%, 30% or 40% or may be within any range delimited by any pair of the foregoing values.
  • the polymer may be a fluoropolymer and the electrospinning solution may have a polymer concentration as little as 5%, 10%, 15% or 20%, or as great as 30%, 35% or 40% or may be within any range delimited by any pair of the foregoing values.
  • FIG 4 provides a schematic illustration of meltblowing.
  • An apparatus 70 is configured to accommodate a polymer melt 72.
  • the polymer melt 72 passes through an orifice 74 and is carried through the orifice 74 via streams of hot air 76 that pass through the apparatus 70.
  • streams of hot air 76 that pass through the apparatus 70.
  • the polymer melt 72 exits the orifice 74, they are met with streams of heated air 78 that helps elongate the polymer melt 72.
  • the polymer melt 72 forms fibers 80 that impinge onto a collector 82.
  • An element to be coated may simply be placed on or in front of the collector 82.
  • the lead 10 may be assembled before the fibrous matrix 40 is formed directly on the lead 10.
  • the fibrous matrix 40 may be formed on a component of the lead 10 before the lead 10 is assembled.
  • the fibrous matrix 40 may be separately formed and then subsequently disposed onto a portion of the lead 10.
  • the fibrous matrix may be formed from more than one polymer material in the form of a composite or material layers.
  • a first layer comprising a first polymer material may be deposited onto a portion of the lead 10, followed by a second layer formed by a second polymer material. Additional layers may also be applied as desired.
  • one of a plurality of layers comprises a non-conductive polymer material while another of the plurality of layers comprises a conductive material.
  • each layer comprises a non-conductive material.
  • fibrous matrix 40 may be on any medical electrical device such as but not limited to implantable electrical stimulation systems including neurostimulation systems such as spinal cord stimulation (SCS) systems, deep brain stimulation (DBS) systems, peripheral nerve stimulation (PNS) systems, gastric nerve stimulation systems, cochlear implant systems, and retinal implant systems, among others, and cardiac systems including implantable cardiac rhythm management (CRM) systems, implantable cardioverter-defibrillators (ICD's), and cardiac resynchronization and defibrillation (CRDT) devices, among others.
  • implantable electrical stimulation systems including neurostimulation systems such as spinal cord stimulation (SCS) systems, deep brain stimulation (DBS) systems, peripheral nerve stimulation (PNS) systems, gastric nerve stimulation systems, cochlear implant systems, and retinal implant systems, among others
  • cardiac systems including implantable cardiac rhythm management (CRM) systems, implantable cardioverter-defibrillators (ICD's), and cardiac resynchronization and defibrillation (CRDT) devices, among others.
  • a group of coil pacing lead electrodes were tested for resistance over a series of 20 shocks at pulse intervals of 10 seconds.
  • Comparative Samples A and B were pacemaker leads including commercially available electrodes produced with a tissue growth inhibition process.
  • Samples C-F were formed from the same type of lead as Samples A and B but the electrodes were coated with a fibrous matrix of Tecothane 55D, commercially available polyether polyurethane, deposited on the electrode by electrospinning.
  • a coating solution containing 5 wt% Tecothane in dimethylacetamide was prepared. The coating solution was loaded into a single needle electrospinning apparatus approximately 10 centimeters (cm) from the electrode surface. The electrospinning apparatus was used to deposit the fibrous matrix onto the electrode under ambient conditions to form a coating thickness of approximately 0.051 mm (0.002 in.).
  • Figure 5 provides a graphical representation of the impedance testing. While Comparative Sample A and Sample B provide the lowest resistance and least variability, Samples C-F exhibited comparable resistance near 45 ohms over the course of the 20 pulses. This indicates that the fibrous matrix did not substantially increase the impedance of the electrode.
  • Comparative Sample G was a pacemaker lead including a commercially available electrode produced with a tissue growth inhibition process.
  • Samples H, I and J were formed from the same type of lead as Comparative Sample G, but the electrodes were covered with a fibrous matrix of poly(vinylidene fluoride-co-hexafluoropropene)(PVDF HFP), a commercially available fluoropolymer including poly(vinylidene fluoride, deposited on the electrode by electrospinning.
  • PVDF HFP poly(vinylidene fluoride-co-hexafluoropropene)
  • the coating solution was loaded into a single needle electrospinning apparatus approximately 10 centimeters from the electrode surface.
  • the electrospinning apparatus was used to deposit the fibrous matrix onto the electrode under ambient conditions.
  • Six leads were covered for each Sample with fibrous matrix thicknesses ranging from 0.018 mm to 0.051 mm (0.0007 in. to 0.002 inches).
  • the samples were then treated with a poly(ethylene glycol) dimethacrylate solution to increase wettability.
  • Figure 6 provides a graphical representation of the impedance testing. While Sample G provided the lowest resistance and least variability, Samples H-J exhibited comparable resistance over the course of the 20 pulses. This indicates that the fibrous matrix did not substantially increase the impedance of the electrode.
  • a shocking coil was implanted subcutaneously into patient tissue. Thirty days after implantation, an incision was made at one end of the shocking coil. The end of the coil was excised out of the tissue and attached to an Instron force gauge. The maximum force to completely extract the coil from under the skin longitudinally was recorded. A greater the extraction force indicates a greater degree of tissue adhesion or tissue ingrowth.
  • a suitable product may have an extraction force less than or about equivalent to a currently commercially available product.
  • Sample K included a polycarbonate urethane fibrous matrix, having an average fiber size of about 0.3 microns and Sample L included a polycarbonate urethane fibrous matrix having an average fiber size of about 0.750 microns.
  • the fibrous matrixes of Samples K and L were formed by electrospinning and had a thicknesses ranging from 0.013 millimeters (mm) to 0.051 mm (0.0005 inches (in) to 0.002 in).
  • Comparative Sample M and Comparative Sample N were commercially available coils produced by different tissue growth inhibition processes. The tissue extraction results in newtons (N) are provided in Table 1. Table 1 Sample K Sample L Comparative Sample M Comparative Sample N Average Max force (N) 2.61 4.68 1.49 3.75 Standard Deviation 0.166 0.098 0.335 0.362
  • a fibrous matrix having an average diameter of 0.3 microns (Sample K) required less force to extract than a fibrous matrix having an average diameter of about 0.750 microns (Sample L), illustrating that the extraction force required decreases with reduced fiber diameters.
  • Sample K required a slightly greater extraction force than commercially available coil Sample M and less force to extract than commercially available coil Sample N.
  • Sample L required more force to extract than Sample M and Sample N.
  • Samples O and P included a PVDF HFP fibrous matrix having an average fiber diameter of about 0.730 microns.
  • the fibrous matrixes of Samples O and P were formed by electrospinning and had a thickness ranging from 0.013 mm to 0.051 mm (0.0005 in to 0.002 in).
  • Comparative Sample Q and Comparative Sample R were commercially available coils produced with different tissue growth inhibition processes. The tissue extraction results in newtons (N) are presented in Table 2. Table 2 Sample O Sample P Comparative Sample Q Comparative Sample R Average Max force (N) 6.79 7.84 2.36 4.60 Standard Deviation 0.222 0.546 0.334 0.459

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Claims (13)

  1. Dérivation électrique médicale (10) comprenant :
    un corps de dérivation isolant (12) qui s'étend depuis une région distale jusqu'à une région proximale ;
    un conducteur (32) qui est disposé à l'intérieur du corps de dérivation isolant (12) et qui s'étend depuis la région proximale jusqu'à la région distale ;
    une électrode (28) qui est disposée sur le corps de dérivation isolant et qui est en contact électrique avec le conducteur ; et
    une matrice fibreuse (40) qui est disposée au moins partiellement au-dessus de l'électrode, la matrice fibreuse étant formée à partir de fibres en un polymère non conducteur qui incluent des fibres qui comprennent du poly(fluorure de vinylidène-co-hexafluoropropène) (PVDF HFP), et présentant un diamètre de fibre moyen qui va de 150 nanomètres à 730 nanomètres, dans laquelle la matrice fibreuse (40) présente une épaisseur qui se situe entre 0,0127 millimètre et 0,0762 millimètre.
  2. Dérivation électrique médicale selon la revendication 1, dans laquelle la matrice fibreuse (40) comprend du PVDF HFP électrofilé.
  3. Procédé de formation d'une dérivation électrique médicale (10) qui comporte un corps de dérivation isolant (12) et une électrode (28) qui est disposée sur le corps de dérivation isolant (12), le procédé comprenant les étapes qui sont constituées par :
    la formation d'une matrice fibreuse (40) un partir de fibres en un polymère non conducteur qui incluent des fibres qui comprennent du poly(fluorure de vinylidène-co-hexafluoropropène) (PVDF HFP) par électro-filage ou par fusion-soufflage ; et
    la disposition de la matrice fibreuse (40) au moins partiellement au-dessus de l'électrode (28), dans lequel la matrice fibreuse (40) présente un diamètre de fibre moyen qui va de 150 nanomètres à 730 nanomètres, dans lequel une épaisseur de la matrice fibreuse se situe entre 0,0127 millimètre et 0,0762 millimètre.
  4. Procédé selon la revendication 3, dans lequel la formation de la matrice fibreuse (40) comprend l'électrofilage de polyuréthane.
  5. Procédé selon la revendication 4, dans lequel, avant l'électrofilage, une solution de revêtement qui comprend entre 1 % et 30 % en poids de polyuréthane est préparée.
  6. Procédé selon l'une quelconque des revendications 3 ou 4, dans lequel la formation de la matrice fibreuse (40) comprend la fusion-soufflage de polyuréthane.
  7. Procédé selon l'une quelconque des revendications 3 à 6, dans lequel la formation de la matrice fibreuse (40) comprend l'électrofilage de fluorure de polyvinylidène.
  8. Procédé selon la revendication 7, dans lequel, avant l'électrofilage, une solution de revêtement qui comprend de 10 % à 40 % en poids de fluorure de polyvinylidène est préparée.
  9. Procédé selon l'une quelconque des revendications 3 à 8, dans lequel la formation de la matrice fibreuse (40) comprend la fusion-soufflage de fluorure de polyvinylidène.
  10. Procédé selon l'une quelconque des revendications 3 à 9, dans lequel la formation de la matrice fibreuse (40) comprend la formation de la matrice fibreuse (40) directement sur l'électrode.
  11. Procédé selon l'une quelconque des revendications 3 à 10, dans lequel la formation de la matrice fibreuse (40) comprend la formation de la matrice fibreuse (40) sur un substrat et le dépôt de la matrice fibreuse au moins partiellement au-dessus de l'électrode.
  12. Procédé selon l'une quelconque des revendications 3 à 11, dans lequel la matrice fibreuse (40) présente un espacement fibre à fibre qui s'inscrit dans une plage de 10 micromètres à 25 micromètres de manière à administrer une thérapie électrophysiologique par l'intermédiaire/au travers de la matrice (40).
  13. Dérivation électrique médicale (10) selon l'une quelconque des revendications 1 ou 2, dans laquelle la matrice fibreuse (40) présente un espacement fibre à fibre qui s'inscrit dans une plage de 10 micromètres à 25 micromètres de manière à administrer une thérapie électrophysiologique par l'intermédiaire/au travers de la matrice (40).
EP12766193.2A 2011-08-12 2012-08-10 Procédé de revêtement de dispositifs à l'aide d'électrofilage et de soufflage à l'état fondu Not-in-force EP2741809B1 (fr)

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US9132269B2 (en) 2015-09-15
AU2012295332B2 (en) 2014-12-04
US8965531B2 (en) 2015-02-24
US20140324141A1 (en) 2014-10-30
JP2016083578A (ja) 2016-05-19
US8903506B2 (en) 2014-12-02
US20150088238A1 (en) 2015-03-26
AU2012295332A1 (en) 2014-02-13
JP2014525279A (ja) 2014-09-29
US20150343200A1 (en) 2015-12-03
US9415206B2 (en) 2016-08-16
EP2741809A1 (fr) 2014-06-18
JP6268207B2 (ja) 2018-01-24
US20130041442A1 (en) 2013-02-14

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